CN101869552B - Preparation method of chitin tablet - Google Patents

Preparation method of chitin tablet Download PDF

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Publication number
CN101869552B
CN101869552B CN2009101392606A CN200910139260A CN101869552B CN 101869552 B CN101869552 B CN 101869552B CN 2009101392606 A CN2009101392606 A CN 2009101392606A CN 200910139260 A CN200910139260 A CN 200910139260A CN 101869552 B CN101869552 B CN 101869552B
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chitin
tablets
preparation
tablet
dextrin
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CN101869552A (en
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吴汝林
王繁业
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Qingdao University of Science and Technology
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Abstract

本发明涉及一种甲壳素片剂的制备方法。该制备方法是将甲壳素原料粉碎过60目筛后,加入3%羟丙甲纤维素和6%的淀粉浆作粘合剂,制成软材,然后用16目网制粒,将颗粒干燥,然后将颗粒粉碎过100目筛。在粉碎好的细粉中加入一定量的磷酸氢钙、糊精、滑石粉和硬脂酸镁,用混料机混合均匀,根据要求压成一定规格的片剂,该方法制备的甲壳素片符合普通片剂的质量要求。The invention relates to a preparation method of chitin tablets. The preparation method is to crush the chitin raw material through a 60-mesh sieve, add 3% hypromellose and 6% starch slurry as a binder to make a soft material, and then use a 16-mesh net to granulate and dry the granules , and then crush the particles through a 100-mesh sieve. Add a certain amount of calcium hydrogen phosphate, dextrin, talcum powder and magnesium stearate to the pulverized fine powder, mix evenly with a mixer, and press into tablets of certain specifications according to requirements. The chitin tablets prepared by this method It meets the quality requirements of ordinary tablets.

Description

一种甲壳素片剂的制备方法A kind of preparation method of chitin tablet

技术领域 technical field

本发明涉及药用片剂的制备方法,具体地说,是一种甲壳素片剂的制备方法。The invention relates to a preparation method of a medicinal tablet, in particular to a preparation method of a chitin tablet.

背景技术 Background technique

甲壳素是自然界中贮存量仅次于纤维素而广泛存在的一种生物多聚物。甲壳素又名甲壳质、几丁质,化学名为聚-N-乙酰-D-葡糖胺,是一种化学结构与纤维素类似的高分子多糖。它广泛存在于昆虫、甲壳类动物的硬壳以及菌类的细胞壁中,是地球上储存量最丰富的有机物之一。近几年来,对甲壳素及其衍生物在医药上的研究提供了许多有价值的资料,展示了其在此领域广阔的应用前景。由于资源丰富、价格便宜、安全无毒及应用广泛等特点,世界各国都十分重视开发和利用。Chitin is a kind of biopolymer widely existing in nature after storage capacity of cellulose. Chitin, also known as chitin and chitin, is chemically called poly-N-acetyl-D-glucosamine, and is a polymer polysaccharide with a chemical structure similar to cellulose. It is widely found in the hard shells of insects and crustaceans and the cell walls of fungi, and is one of the most abundant organic substances stored on the earth. In recent years, the research on chitin and its derivatives in medicine has provided a lot of valuable information, showing its broad application prospects in this field. Due to the characteristics of abundant resources, cheap price, safety and non-toxicity and wide application, all countries in the world attach great importance to the development and utilization.

日本学者经体液性免疫和细胞性免疫试验证明,甲壳素具有促进免疫的功能,可制成散剂、颗粒剂口服,作为免疫增强剂。甲壳素可络合、螯合重金属,吸附体内有害物质并排出体外;可激活免疫因子,强化人体免疫功能,改善睡眠,消除疲劳;其碱性物质可改善酸性体系,保护肠胃,促进肠胃康复;可以消除人体自由基,阻碍脂肪的吸收,促进胆固醇的转化,有效降低血脂等。Japanese scholars have proved by humoral immunity and cellular immunity tests that chitin has the function of promoting immunity, and it can be made into powder or granule orally as an immune enhancer. Chitin can complex and chelate heavy metals, absorb harmful substances in the body and excrete them; it can activate immune factors, strengthen the immune function of the human body, improve sleep, and eliminate fatigue; its alkaline substances can improve the acid system, protect the stomach, and promote the recovery of the stomach; It can eliminate free radicals in the human body, hinder the absorption of fat, promote the conversion of cholesterol, and effectively reduce blood lipids.

目前市场上已有功能性甲壳素胶囊产品,但由于甲壳素原粉极易吸潮,做成功能性片剂受到了一定的限制。为了满足市场需求,根据我们对药剂学知识的理解,结合甲壳素的物理性质,我们开发了符合要求的甲壳素片剂,制备的甲壳素片剂符合普通片剂的药用质量要求。At present, there are functional chitin capsule products on the market, but because chitin raw powder is very easy to absorb moisture, it is limited to make functional tablets. In order to meet the market demand, based on our understanding of pharmacy knowledge and combined with the physical properties of chitin, we have developed chitin tablets that meet the requirements, and the prepared chitin tablets meet the pharmaceutical quality requirements of ordinary tablets.

发明内容 Contents of the invention

本发明的目的是提供一种甲壳素片剂的制备方法。该制备方法工艺简单、制造成本低,具有良好的商业化前景。The purpose of this invention is to provide a kind of preparation method of chitin tablet. The preparation method has simple process, low manufacturing cost and good commercial prospect.

为了达到上述目的,本发明采用以下技术方案:In order to achieve the above object, the present invention adopts the following technical solutions:

将甲壳素原料过筛后,加入粘合剂,制成软材。然后用筛网制粒,将颗粒干燥后粉碎过筛。在制备好的粉末中加入一定量的赋形剂,用混料机混合均匀,根据要求压成一定规格的片剂,该方法制备的甲壳素片符合普通片剂的质量要求。After the chitin raw material is sieved, a binder is added to make a soft material. The granules are then granulated with a sieve, the granules are dried and crushed and sieved. A certain amount of excipient is added to the prepared powder, mixed evenly with a mixer, and pressed into tablets with certain specifications according to requirements. The chitin tablets prepared by this method meet the quality requirements of ordinary tablets.

所述的粘合剂为10%的淀粉浆、8%的淀粉浆、6%的淀粉浆、4%的淀粉浆、2%的淀粉浆、6%的羟丙甲纤维素、3%的羟丙甲纤维素、1%的羟丙甲纤维素、8%的淀粉浆和1%的羟丙甲纤维素、4%的淀粉浆和6%的羟丙甲纤维素、6%的淀粉浆和3%的羟丙甲纤维素。优选的是6%的淀粉浆和3%的羟丙甲纤维素、8%的淀粉浆和1%的羟丙甲纤维素。特别优选的是6%的淀粉浆和3%的羟丙甲纤维素。Described binder is 10% starch slurry, 8% starch slurry, 6% starch slurry, 4% starch slurry, 2% starch slurry, 6% hypromellose, 3% hydroxypropyl methylcellulose Promellose, 1% hypromellose, 8% starch slurry and 1% hypromellose, 4% starch slurry and 6% hypromellose, 6% starch slurry and 3% hypromellose. Preferred are 6% starch slurry and 3% hypromellose, 8% starch slurry and 1% hypromellose. Especially preferred is 6% starch slurry and 3% hypromellose.

所述的赋形剂为乳酸钙、碳酸钙、磷酸氢钙、糊精、滑石粉、硬脂酸镁。优选的赋形剂为碳酸钙、磷酸氢钙、糊精、滑石粉、硬脂酸镁。特别优选的是磷酸氢钙、糊精、滑石粉、硬脂酸镁。The excipients are calcium lactate, calcium carbonate, calcium hydrogen phosphate, dextrin, talcum powder and magnesium stearate. Preferred excipients are calcium carbonate, calcium hydrogen phosphate, dextrin, talc, magnesium stearate. Particularly preferred are calcium hydrogen phosphate, dextrin, talc, magnesium stearate.

所述的赋形剂磷酸氢钙的加入量为10-30%。优选的是磷酸氢钙的加入量为10-15%。特别优选的是磷酸氢钙的加入量为11%。The added amount of the excipient calcium hydrogen phosphate is 10-30%. Preferably the addition of calcium hydrogen phosphate is 10-15%. It is particularly preferred that the addition of calcium hydrogen phosphate is 11%.

所述的赋形剂糊精的加入量为5-20%。优选的是糊精的加入量为5-8%。特别优选的是糊精加入量为5%。The added amount of the excipient dextrin is 5-20%. Preferably, the added amount of dextrin is 5-8%. It is particularly preferred that the added amount of dextrin is 5%.

所述的赋形剂滑石粉的加入量为3-13%。优选的是滑石粉的加入量为3-8%。特别优选的是滑石粉的加入量为3%。The added amount of the excipient talcum powder is 3-13%. Preferably, the added amount of talcum powder is 3-8%. Particularly preferred is the addition of talc in an amount of 3%.

所述的赋形剂硬脂酸镁的加入量为0.5-1.5%。优选的是硬脂酸镁的加入量为0.5-0.8%。特别优选的是硬脂酸镁的加入量为0.5%。The added amount of the excipient magnesium stearate is 0.5-1.5%. Preferably, the added amount of magnesium stearate is 0.5-0.8%. It is particularly preferred that the added amount of magnesium stearate is 0.5%.

所述的赋形剂磷酸氢钙、糊精、滑石粉、硬脂酸镁以粉末状态加入。The excipients calcium hydrogen phosphate, dextrin, talcum powder and magnesium stearate are added in powder state.

所述的赋形剂磷酸氢钙、糊精、滑石粉、硬脂酸镁是在制备的颗粒粉碎过100目筛后加入。The excipients calcium hydrogen phosphate, dextrin, talcum powder and magnesium stearate are added after the prepared granules are crushed through a 100-mesh sieve.

本发明所述的甲壳素的制备方法,更具体地,包含以下步骤:The preparation method of chitin of the present invention, more specifically, comprises the following steps:

(1)颗粒的制备(1) Preparation of particles

将甲壳素原料过60目筛,加入到槽型混料机中。配制好3%的羟丙甲纤维素和6%的淀粉浆,加入到混料机中,搅拌40分钟制成软材。然后用16目网的制粒机制粒,将湿颗粒用沸腾气流床干燥,得到干燥的颗粒。Pass the chitin raw material through a 60-mesh sieve and add it to the tank mixer. Prepare 3% hypromellose and 6% starch slurry, add in the mixer, stir for 40 minutes to make soft material. Then use a granulator with a 16-mesh mesh to granulate, and dry the wet granules with a boiling air-flow bed to obtain dry granules.

(2)片剂的制备(2) Preparation of tablets

将上述的干颗粒粉碎过100目筛,加入一定量的药用级的磷酸氢钙、糊精、滑石粉和硬脂酸镁,磷酸氢钙、糊精、滑石粉和硬脂酸镁提前过100目筛。用三维混料机混合均匀,计算片重后用压片机压成一定形状和规格的片剂。经检验,所压片剂符合普通片剂的质量要求。The above-mentioned dry granules are crushed through a 100-mesh sieve, and a certain amount of pharmaceutical grade calcium hydrogen phosphate, dextrin, talcum powder and magnesium stearate is added, and the calcium hydrogen phosphate, dextrin, talc powder and magnesium stearate are passed through 100 mesh sieve. Mix evenly with a three-dimensional mixer, calculate the weight of the tablet, and press it into a tablet of a certain shape and specification with a tablet press. After inspection, the compressed tablets meet the quality requirements of ordinary tablets.

本发明制备方法得到的甲壳素片剂,经检验和分析仪器检测,所压片剂的崩解度、卫生标准等符合片剂的质量要求。The chitin tablet obtained by the preparation method of the present invention is tested by inspection and analysis instruments, and the disintegration degree, hygienic standard and the like of the compressed tablet meet the quality requirements of the tablet.

本发明具有工艺简单、生产成本低等特点,特别适合于工业化生产。The invention has the characteristics of simple process and low production cost, and is especially suitable for industrialized production.

具体实施方式 Detailed ways

下面是本发明的实施例,所述的实施例只是用来说明本发明,而不应当被视为是对本发明的限制。The following are examples of the present invention, which are only used to illustrate the present invention, and should not be regarded as limiting the present invention.

实施例Example

称取甲壳素原料420g,加入6%的淀粉浆和3%的羟丙甲纤维素组成的混合浆作粘合剂,制备软材,过16目筛制成湿颗粒,用烘箱烘干,将颗粒粉碎过100目筛,加入已过100目筛的磷酸氢钙11%、糊精5%、滑石粉3%、硬脂酸镁0.5%的干粉填加剂混匀,用压片机压成1000片。经检验,所压甲壳素片剂符合普通片剂的质量要求。Weigh 420g of chitin raw material, add 6% starch slurry and 3% hypromellose mixed slurry as binder, prepare soft material, pass through 16 mesh sieves to make wet granules, dry in an oven, and The granules are crushed through a 100-mesh sieve, added with 11% calcium hydrogen phosphate, 5% dextrin, 3% talcum powder, and 0.5% magnesium stearate dry powder additives that have passed through a 100-mesh sieve, mixed evenly, and pressed into a tablet. 1000 pieces. After inspection, the pressed chitin tablets meet the quality requirements of ordinary tablets.

以上对本发明所提供的甲壳素片剂的制备方法进行了详细介绍,本文中应用了具体个例对本发明的原理及实施方式进行了阐述,以上实施例的说明只是用于帮助理解本发明的方法及其核心思想;同时,对于本领域的一般技术人员,依据本发明的思想,在具体实施方式及应用范围上均会有改变之处,综上所述,本说明书内容不应理解为对本发明的限制。The preparation method of the chitin tablet provided by the present invention has been described in detail above, and the principle and implementation of the present invention have been explained by using specific examples in this paper. The description of the above examples is only used to help understand the method of the present invention and its core idea; at the same time, for those of ordinary skill in the art, according to the idea of the present invention, there will be changes in the specific implementation and scope of application. limits.

Claims (1)

1. the method for preparing of a chitin tablet is characterized in that, comprises following steps:
Take by weighing chitin raw material 420g; The mixed pulp that the starch slurry of adding 6% and 3% hypromellose are formed is made binding agent, and the preparation soft material is crossed 16 mesh sieves and processed wet granular; Use oven for drying; Granule was pulverized 100 mesh sieves, added the dry powder compound mixing of the calcium hydrogen phosphate 11% of crossing 100 mesh sieves, dextrin 5%, Pulvis Talci 3%, magnesium stearate 0.5%, be pressed into 1000 with tablet machine.
CN2009101392606A 2009-04-25 2009-04-25 Preparation method of chitin tablet Expired - Fee Related CN101869552B (en)

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Publication number Priority date Publication date Assignee Title
CN105012943A (en) * 2015-07-17 2015-11-04 青岛海之星生物科技有限公司 Phosphoesterases complex and chitin compound sustained-release capsule and preparation method thereof
CN104983707A (en) * 2015-07-17 2015-10-21 青岛海之星生物科技有限公司 Composite phosphoesterase and chitin compound sustained release tablet and preparation method thereof

Citations (4)

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Publication number Priority date Publication date Assignee Title
JP2004262860A (en) * 2003-03-03 2004-09-24 Fancl Corp Chitosan-containing tablet and method for producing the same
CN101053409A (en) * 2007-05-11 2007-10-17 汪昔奇 Health care food containing natural astaxanthin
CN101103994A (en) * 2006-07-13 2008-01-16 中国科学院地理科学与资源研究所 A drug for preventing and treating gout and hyperuricemia
CN101262784A (en) * 2005-09-14 2008-09-10 金镇满 Supplementary food composition for reducing body odor

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004262860A (en) * 2003-03-03 2004-09-24 Fancl Corp Chitosan-containing tablet and method for producing the same
CN101262784A (en) * 2005-09-14 2008-09-10 金镇满 Supplementary food composition for reducing body odor
CN101103994A (en) * 2006-07-13 2008-01-16 中国科学院地理科学与资源研究所 A drug for preventing and treating gout and hyperuricemia
CN101053409A (en) * 2007-05-11 2007-10-17 汪昔奇 Health care food containing natural astaxanthin

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